CE Marking:
The prime regulation
governing medical devices are the
Medical
Device Directives.
We assist you achieve
the necessary approvals for EC distribution
and can act as our Clients Authorised EC
Representative. Accordingly
we work with our clients to:
-
Establish a clear Project
Plan to implement the regulatory and development strategy and liaise with the
necessary authorities.
-
Classify
the device(s) in accordance with pertinent regulations and standards.
-
Select
the best -fit compliance assessment route and subsequent clearance
by the relevant national agencies.
-
Identify regulatory &
harmonised standards to be met.
-
Establish a Technical File
Structure.
-
Prepare design &
development protocols.
-
Prepare prototyping /
verification plans.
-
Identify and Test Materials.
-
Select and contract with specialist
sub-contractors for design, assembly, testing, packaging / labelling and
sterilisation.
-
Select
and liaise with the Notified Body as appropriate.
-
Collate the evidence of performance
and compliance with Standards in the Technical File.
-
Provide
consultancy support services that ensure product, system and regulatory
compliance.
Our
advice to inventors, IP Holders, investors, product designers, developers and
/or manufacturers is to obtain assistance as
soon as possible. Timescales and documentation
requirements for approvals can be
onerous.
Call George Buchan on +44 (0)1292 671555
for a confidential, no obligation
discussion.
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EC: Steps to Market Clearance |
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1.STEP
1: Confirm your Device is a Medical Device, define the device Indications for Use
/ Intended Purpose.
STEP 2: Establish unique device characteristics &
potential performance claims.
What benefits and claims are likely to be made?
STEP 3:
Classify your device in accordance with ANNEX IX.
STEP 4:
Select the Conformity Route for market clearance.
STEP 5:
Prepare a design & development plan
to include regulatory requirements and Risk Management. Define
Standards to be met and establish prototyping / verification
plans.
STEP 6:
Define specifications for design, select / test
materials, define who does what.
:
STEP 7: Establish criterion for selecting Contractors.
Develop Technical Agreements with Suppliers /
Contractors.
STEP 8:
Establish the processes involved, document and implement systems of control, including post market
surveillance. (See ISO 13485:2003)
STEP 9: Collate evidence of of meeting Indications for
Use and Performance Claims
STEP 10:
Complete
Regulatory Application
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